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Quality Control And The Supplement Industry
It seems like every time I turn on the news, I see a supplement company being busted for quality-control issues. The media seem to hop on any negative supplement story any chance they get! What about all the prescriptions that doctors write for patients who don’t even need them? What’s your take on this, Will?
The reporting on dietary supplements versus pharmaceutical drugs is neither balanced nor objective, not by a long stretch. So what of the issues of quality control in the pharmaceutical industry? Are there major infractions that get little media attention that people should know about? Does FDA regulation make that industry inherently safer? The fact is, various pharmaceutical companies regularly fail FDA inspections and have to be forced to comply with manufacturing guidelines via legal action. In fact, the government, via the FDA, has had to levy ever-greater fines on the pharmaceutical industry in recent years simply to force companies to follow existing quality-control regulations and guidelines. What follows is a small sample of shocking and major quality-control problems within the pharmaceutical industry:
- The FDA fined Schering-Plough Corp. $500 million for repeatedly failing plant inspections after the FDA set strict quality-control terms on four Schering-Plough facilities. FDA inspectors found “significant violations regulations related to facilities, manufacturing, quality assurance, equipment, laboratories and labeling.” If that weren't bad enough, the company shipped out asthma inhalers that contained little or no active ingredient (albuterol), leading to perhaps as many as 17 deaths, according to the Public Citizen’s Health Research Group. Several massive recalls were the result.
Once held up as the model of success in biotech, Genzyme Corp, “under the consent decree of permanent injunction,” agreed to correct manufacturing quality violations at one of its facilities and will return $175 million in “unlawful profits” from the sale of products that were made at the plant. According to the FDA, in addition to failing various quality-control issues, some products were “contaminated with metal, fiber, rubber and glass particles.”
- Abbott Laboratories was forced to recall Similac infant formula after insect parts were found in some batches.
Intravenous drugs from Amgen and Novartis were recalled for the presence of glass flakes supposedly caused by a breakdown of materials in the stored vials.
- Johnson & Johnson had to recall nearly 200 million bottles of various over-the-counter drugs due to “foul odor.” According to a Reuters report FDA inspectors “found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape–covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products …” with “… raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to the report dated April 30.” It was so bad, the FDA “…urged consumers to stop using liquid Tylenol, Motrin, Benadryl and Zyrtec for children andinfants after a broad recall…”and recommended that people use generics instead. The company has suspended production at the plant.
“But wait, there’s more!”
As the infomercial announcers always says, “But wait, there’s more!” If the above doesn't shock most readers, the following recent case involving GlaxoSmithKline will leave readers wondering if any drugs are truly safe out there. GlaxoSmithKline recently paid $750 million in civil and criminal penalties for “knowingly selling contaminated, adulterated and ineffective drugs” produced by its now-closed plant in Puerto Rico. Some of the drugs produced at this plant and known to be affected were Paxil, Bactroban, Coreg, Tagamet, and Avandia. As of this writing, the investigation is ongoing, and additional civil and criminal charges may still be handed down. People should be aware that the above examples are by no means an exhaustive list of recent failures of quality control by the pharmaceutical industry.